QTRam®
Portable Raman System for Content Uniformity
The QTRam® is a portable Transmission Raman Spectrometer powered by our patented STRaman® technology optimized for rapid and nondestructive quantitative analysis ideal for content uniformity testing of finished products such as tablets and capsules.
The portable QTRam can be used for at-line quantitation of tablet composition, reducing the time and associated production delays that come from needing to submit samples to the laboratory for in-process and final product testing. Calibrations can be developed for multi competent testing from a single Raman spectrum.
The QTRam can be easily operated using 21CFR Part 11 compliant software for quantitative analysis on the inbuilt tablet computer, while the portable form factor allows users to use it for at-line analysis or in the lab.
Applications:
Content uniformity - ensure the dosage uniformity of the API in solid dosage finished product including tablets, capsules, and gels
Formulation development - support QbD initiatives in quantifying API and excipient concentrations in finished dosage forms
Counterfeit detection – calculate API quantity to ensure correct drug and correct dosage
Features:
• STRaman technology with high-throughput for
transmission Raman spectroscopy over large sample
volumes.
• Easy-to-use 21 CFR Part 11 compliant software for
quick results and reporting
• Portability for at-line or laboratory analysis
• Customizable sample holders to accommodate most
sample dimensions
• Step-by-step, easy-to-follow quantitative modeling
and method developmentBenefits:
• Quantitative sample composition,
crystallinity and polymorphic form
from single measurement
• Rapid quantitative results for one or
more ingredients in seconds
• No sample preparation
• No consumables
• No disposal cost
• USP-recognized transmission Raman
for content uniformity testing
Model
BWS475-785H-CU
Laser Source
785 nm, full power >420 mW at sample with software-adjustable power
Software
21 CFR Pt.11 Compliant BWAnalyst®
System Configuration
Transmission Raman
Power Adaptor
Input: 100-240V AC 50/60 Hz, Output: 12VAC @6.6 Amps
Physical
Main Unit
QT-Sampler®
Dimensions
15.7 in x 10.2 in x 9.8 in
(40 cm x 26 cm x 25 cm)13.01 in x 6.68 in x 6.97 in
(33 cm x 17 cm x 18 cm)Weight
~19.5 lbs (~8.8 kg)
~17.81 lbs (~8.5 kg)
Operating Temperature
0 ˚C – 35 ˚C
Humidity
10% - 85%, non-condensing
Software:
B&W Tek offers comprehensive software packages that provide solutions for Raman application needs. Powerful calculations, easy data management, and user-friendly, easy-to-follow workflows are all at the tips of your fingers.
BWAnalyst® is the touch-screen-operated 21CFR part 11 software with a logical workflow for data acquisition, method building, routine analysis and reporting. Once the method is developed and validated, operators can quickly perform quantitative predictions, getting clear results in seconds that are stored in a secure database. The software has configurable reports, with electronic signatures and a full audit trail.
BWIQ® multivariate analysis software is used to develop quantitative models used in BWAnalyst for predictions.
System Includes:
• QT-Sampler® and two standard sample holders
• Laser safety goggles
• BWAnalyst® touchscreen software
• BWSpec® operating software for exploratory work
• BWIQ® chemometric software
描述 [描述] QTRam®是一款便携式传输拉曼光谱仪,采用STRaman®技术,优化了快速和无损定量分析的成品,如片剂和胶囊的含量均匀性测试。